MAUDE Adverse Event Report: CAREFUSION 303, INC. BD ALARIS; IV PUMP LARGE VOLUME

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 12/03/2017

Event Type  malfunction  

Event Description

Iv pump infused too quickly.I programmed the pump to give the patient pentamidine at a rate of 100ml/hr.The medication bag had 100mls in it according to the label so it should have run over an hour.While the apn was in the room the bag went empty approximately 15 minutes after i started the medication.The patient was given antiemetics and vital signs were checked.The logs confirmed the pump settings were correct.Rate was set at 5, and the vtbi (volume to be infused) was set to 120.I continued my investigation this morning by testing pump (b)(4), and found that it was producing 12.92 milliliters for every 12ml of liquid requested.This is more than 7 percent beyond what was specified.This would explain why it was using more medication in a shorter span of time, than what was expected.Pcu tag (b)(4) last pm'd approx.2 months ago.Iv module tag (b)(4) last pm'd approx.6 months ago.At this facility there have been five incidents with various bd 8100 iv modules that have over delivered medication.The first event was approximately one month ago.The second event was approximately 20 days later.The third and fourth event occurred approximately five weeks after the first event.The 5th event occurred one day after the fourth event.

• Brand Name: BD ALARIS
• Type of Device: IV PUMP LARGE VOLUME
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 8173571
• MDR Text Key: 130641841
• Report Number: 8173571
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2018
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other